STOCKHOLM - Calliditas Therapeutics AB (NASDAQ: CALT) (Nasdaq Stockholm: CALTX) presented additional data from its Phase 3 NeflgArd trial at the ISN World Congress of Nephrology in Buenos Aires. The trial evaluated the efficacy of Nefecon, also known as TARPEYO® and Kinpeygo®, in treating IgA nephropathy (IgAN), a chronic kidney disease.
Chief Medical Officer Richard Philipson expressed that the latest analyses support Nefecon's positive impact on patients with IgAN, regardless of their baseline UPCR levels or racial and ethnic backgrounds.
The trial involved 364 patients and showed that Nefecon consistently improved kidney function over two years compared to placebo. Notably, patients with lower levels of proteinuria (UPCR
The study further revealed that Nefecon's effects were consistent across different racial and ethnic groups, with both Asian and White patients showing favorable changes in kidney function and reduced rates of microhematuria.
TARPEYO is indicated to reduce kidney function loss in adults with primary IgAN at risk of disease progression. However, it carries contraindications for patients with hypersensitivity to budesonide or any of its ingredients. The medication may also cause systemic effects such as hypercorticism and adrenal suppression, particularly in patients with moderate to severe hepatic impairment.
Moreover, patients on TARPEYO may be more susceptible to infections and should monitor for adverse effects such as peripheral edema, hypertension, and muscle spasms.
The NeflgArd study's primary efficacy endpoint was the time-weighted average of eGFR over two years, with results showing a statistically significant benefit of TARPEYO versus placebo. The treatment's impact on eGFR was apparent by month three and persisted after the nine-month treatment period.
IgAN, also known as Berger's Disease, is a rare autoimmune disease that can lead to end-stage renal disease. It often develops in individuals between their late teens and late 30s.
This news is based on a press release statement from Calliditas Therapeutics.
InvestingPro Insights
As Calliditas Therapeutics (NASDAQ: CALT) continues to make strides in the treatment of IgA nephropathy with its Nefecon drug, investors and stakeholders are closely monitoring the company's financial health and market performance. According to real-time data from InvestingPro, Calliditas boasts a robust gross profit margin of 94.99% for the last twelve months as of Q4 2023, reflecting its strong ability to manage production costs and generate earnings.
Despite the challenges in the biotech sector, Calliditas displays an impressive revenue growth of 50.32% during the same period, indicating a significant increase in sales and potential market expansion. However, the company's stock has experienced a notable decline over the last week, with a 1-week price total return of -8.72%, underscoring market volatility that investors should consider.
InvestingPro Tips highlight that while Calliditas is not profitable over the last twelve months, analysts predict the company will turn a profit this year. Additionally, the company's liquid assets exceed short-term obligations, suggesting a strong liquidity position that could support ongoing operations and research endeavors. For investors seeking more comprehensive analysis, InvestingPro offers additional tips on Calliditas, which can be accessed at https://www.investing.com/pro/CALT. There are 9 more InvestingPro Tips available for Calliditas, providing deeper insights into the company's financial and operational performance.
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